Clinical Data and Analytics Lead Integrated Resources, IncClinical Data and Analytics LeadCambridge, MassachusettsFull timeQualifications• 5+ years relevant work experience with a focus on data management • Deep understanding of drug development and biopharmaceutical industry required • Strong project management skills, and ability to effectively lead and collaborate with various business functions • High attention to detail including proven ability to manage multiple competing priorities • Experience overseeing outsourced clinical trials work performed by vendors • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at vendor • Deep knowledge of clinical data management with full-service global CROs and FSPs • Demonstrated ability to influence without authority • Excellent written and oral communication skill Primary contact between Data Management and clinical study management teams (SMT and/or Clinical Development Team representatives).Liaises directly with internal customers (Medical functions, Statistical Programming, Clinical Operations, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel).Serves as Subject Matter Expert for data, reporting, and analysis process definition, improvement, and innovation as needed.
Clinical Research Associate II/III - US Optimapharm ddClinical Research Associate II/III - USBoston, MARemoteWith operations in 40+ countries and 2x the patient reach of the average mid-sized CRO, we enable accelerated regulatory pathways, faster study start-up, and access to diverse patient populations worldwide. As we expand our US Clinical Operations team, we're searching for a CRA II/III who is motivated by quality, driven by purpose, and eager to contribute to innovative clinical research that changes lives.
Lead Clinical Data Manager. Integrated Resources, IncLead Clinical Data Manager.Lexington, MassachusettsFull timeTakes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve resultsCourage to challenge: Takes risks and challenges norms to support tomorrow's needs Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to DMOperations Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer's decision making Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines. protocols, SAPs)Building Authentic Relationships: Building trusting relationships that will enhance current and future needs Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success Key Skills, Abilities, andCompetencies:Must be able to produce data management reports Strong attention to detail and accuracy is a must.
Clinical Research Coordinator - Center of Cancer Therapeutic Innovation Dana-Farber Cancer Institute IncClinical Research Coordinator - Center of Cancer Therapeutic InnovationBOSTON, MA$48,100–$54,400 / yearThe CRC (Clinical Research Coordinators) work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
Clinical Study Manager Integrated Resources, IncClinical Study ManagerCambridge, MassachusettsFull timeProvides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report. 11 identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
Clinical Safety Data Manager Integrated Resources, IncClinical Safety Data ManagerCambridge, MassachusettsFull timeActs as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials 10%Qualifications•Minimum of Bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required•Master's or Doctorate level degree in health care related profession preferredMinimum Experience Requirements:•4+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent•Experience interacting with clinical third parties (e.g., contract research organizations) preferred•Knowledgeable in Pharmacovigilance and GCP legislation required•Direct experience in GXP compliant quality systems preferred The AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others ) to ensure consistency with regulations and with departmental goals and objectives.
Clinical Trials Safety Data Manager Integrated Resources, IncClinical Trials Safety Data ManagerCambridge, MassachusettsContractorConduct partner oversight and performance management on contracted work (e.g., monitoring reports, quality evaluations, annual meetings) Senior Manager, Safety Data Collection, Clinical Trials.• Communicates on PV legislation and regulatory commitments across the organization and externally Senior Manager, Safety Data Collection, Clinical Trials.• Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials. Report metrics and KPIs for Clinical Trial safety report collection Senior Manager, Safety Data Collection, Clinical Trials.• Oversee and ensure study safety operational requirements are operationalized Senior Manager, Safety Data Collection, Clinical Trials.• Support the following Strategic Partner / vendor oversight activities, in conjunction with relevant functions (such as Global Clinical Operations) in relation to Clinical Trial safety report collection.•
Clinical Data Manager Integrated Resources, IncClinical Data ManagerCambridge, MassachusettsContractorReview study database design and derivations to ensure the database will meetReview study validations and/or edit checks to ensure the quality of the dataManage Analytical Sciences project plan, report on progress of Analytical Sciences deliverables, identify and resolve issues, coordinate activities with the project team and management for assigned compoundsAnticipate and communicate resource and quality issues that may impact deliverables or timelines for a program or group of studies. Represents DM function on major matters regarding policies, plans and objectives and industry meetings as well as serve as a role model and mentor and thought leader for DM.Actively mentors Data Managers and Senior Data Managers.
Clinical Research Assistant II Beth Israel Lahey HealthClinical Research Assistant IIBoston, MassachusettsCustomer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols.
Clinical & Translational Research Unit Lab Technician I Boston Children's HospitalClinical & Translational Research Unit Lab Technician IBoston, MAUnder direct supervision of the BCH Clinical & Translational Research Unit (CTRU) lab supervisor, the primary on-site lab technician lab handles, processes and manages specimens entering the CTRU lab from research participants throughout the institution. Completes assigned tasks such as assisting with monitoring and maintenance of lab equipment, lab-related inquiries, and Clinical Research Operations (CRO) Continuous Quality Improvement projects and lab sample tracking database.
NewRegulatory Coordinator II - Clinical Trial Office Dana-Farber Cancer Institute IncRegulatory Coordinator II - Clinical Trial OfficeBrookline, MARemote$61,110–$67,900 / yearThis position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc.
Senior Clinical Research Accounting Specialist Dana-Farber Cancer Institute IncSenior Clinical Research Accounting SpecialistBROOKLINE, MA$88,700–$98,000 / yearActively manages and tracks study financial activity across multiple complex disease centers and sites of service in the Clinical Trials Management System (CTMS) and works closely with study teams to ensure financial activity is up to date. Prepares accounts payable reports including payment of hospital bills, professional bills, internal and external research site bills, and vendor bills including tracking and troubleshooting charge posting errors.
Senior Manager, Clinical Study Quality Lead (Hybrid) Vertex Pharmaceuticals, IncSenior Manager, Clinical Study Quality Lead (Hybrid)Boston, MARemote$137,800–$206,800 / yearGeneral Summary: The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. This is an individual contributor role focused on GCP quality assurance oversight for clinical trials, including risk-based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, and inspection readiness.
NewSenior Manager, Clinical Study Quality Lead Vertex PharmaceuticalsSenior Manager, Clinical Study Quality LeadBoston, MassachusettsRemoteThe Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. This is an individual contributor role focused on GCP quality assurance oversight for clinical trials, including risk-based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, and inspection readiness.
Clinical Research Coordinator II - Attleboro Dana-Farber Cancer Institute IncClinical Research Coordinator II - AttleboroAttleboro, MA$56,000–$62,700 / yearThis Satellite Clinical Research Coordinator position will work within the Dana-Farber Attleboro Satellite location supporting the clinical research program and research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI disease programs. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
RN Clinical Research Nurse / Dana-Farber Cancer Center South Shore Health Systems IncRN Clinical Research Nurse / Dana-Farber Cancer CenterWeymouth, MAIn addition, the Research Nurse utilizes evidence-based nursing practice and has expertise in developing and coordinating a plan of care designed to meet the physical, psychological, and social needs of those cancer patients and their families undergoing therapy in a clinical research trial. Participates in Division of Nursing / Institute committees at the main DFCI Longwood campus, including, but not limited to, the monthly Research Nurse Practice Committee meeting.
Clinical Research Assistant Brown University HealthClinical Research AssistantEast Providence, RI$41,537.60–$68,556.80 / yearBrown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. The overall objective of this study is to test a new clinical model to engage and retain Latin X/ Hispanic (L/H) youth and their caregivers in culturally centered, evidence based treatment (EBT) for the prevention and treatment of suicidal behaviors(SB).
Senior Medical Director Clinical Research - Neurodegeneration Alnylam Pharmaceuticals IncSenior Medical Director Clinical Research - NeurodegenerationMABoard Certification (or equivalent) or specialist training is highly desirable; drug development experience in neurology (Huntington's Disease) would be a great advantage, but not essential 10+ years industry experience or equivalent clinical academic experience Sound scientific and clinical judgment Successful track record of leading Phase 2/3 clinical programs (preferably in Huntington's drug development), including major interactions with Health Authorities Familiarity with concepts of clinical research and clinical trial design, including biostatistics, regulatory agency organization, guidelines, and practices Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues Outstanding leadership and collaboration skills working within a matrix environment. Collaborate closely with Preclinical, Regulatory Affairs, Medical Affairs and Commercial to ensure tight strategic integration of product development plans Be accountable via Clinical Research and Operations for all relevant timelines and deliverables Drive/supervise all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials Be responsible (as appropriate in line with SOPs) for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms Influence internal and external audiences in a high impact, highly visible fashion MD with strong research background or MD PhD, with a track record of successful research support and peer review publications.
Director Clinical Research Alnylam Pharmaceuticals IncDirector Clinical ResearchCambridge, MA$255,000–$345,000 / yearBoard Certification (or equivalent) or specialist training in cardiology Expertise in heart failure and/or amyloidosis is desirable 3+ years industry experience or equivalent clinical academic experience Sound scientific and clinical judgment Familiarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practices Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues Outstanding leadership and collaboration skills working within a matrix environment Experience and knowledge of working with biotech/pharma partner(s) Thrives in highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion and urgency. Influence internal and external audiences in a high impact, highly visible fashion A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role.
Clinical Database Analyst Integrated Resources, IncClinical Database AnalystLexington, MassachusettsFull timeGenerate user requirements documentation and setup UATo Move visualizations to production through the development stages (dev/qa/prod) per existing process• Visualizations for Medical Reviewo Load the clinical trial datasets (in Study Data Tabulation Model) in Spotfire/iDARTso Map existing data visualization templates in iDARTs to the clinical trial datasetso Collect additional user requirements (from study physicians & data managers) and design new visualizations (Tables/Graphs)o Design new visualizations (Tables/Graphs) based on the user requirementso Conduct review sessions with the study team memberso Follow-up on needed improvements and changes neededo Move visualizations to production through the development stages (dev/qa/prod) per existing process 50%Decision-Making and Problem-Solving:Position requires an open mindset with good issue identification and problem-solving skills. Working Relationships/Interfaces:Primarily interacts with• ARBM team members (SAS Programmers and Central Monitors)• Clinical study team members (Clinical Scientist, Study Physician, Global Data Manager)• As needed, interacts with other staff within R&D (eg, biostats & programming)Education & Experience Requirements:• Minimum of a BS/BA degree or professional experience equivalent• At least 1 year relevant experience in pharmaceutical or health care industry• Advanced knowledge of TIBCO Spotfire required• Experience in working with clinical data (plus a general understanding of clinical trials) strongly preferredQualities and Characteristics:• Communication skills and active listening• Strong customer focus• Strong analytical mindset & Quality oriented• Innovative thinking• Flawless execution